Californian Consent

If the United States was the King’s court, California may be its jester- a state where popular referendum rules, where hulking actors and internet flea market CEOs vie for governorship, the home of Beverly Hills cops, scientologists, daisy dukes, and a host of other ridiculous phenomena. It comes as no surprise then that California may be in serious violation of certain guiding bioethical principles.

After a child is born in California, doctors dab a few drops of blood on a blood card to test for 77 genetic diseases. As necessary as these life-saving tests are, parents wonder why the genetic material is being kept by the state as property indefinitely. The cards are shuttled after the tests to scientific researchers who store the genetic material in a databank. California now has an inventory of 15-million cards that can be used later when necessary for “research, lawsuits, and investigations” (KTVU). From the state’s perspective, if the option is available, it sees no trouble in availing it for a good cause. Furthermore, doctors notify parents about the blood cards in paperwork they read after the delivery.

Unfortunately, that doesn’t quite cut it for a lot of parents. Diana Oros recalls, “They might have given me a piece of paper, but it was right after birth. We were tired. There was so much going on we didn’t have time to read anything.” Though the doctors tried to receive ‘consent,’ it was clearly far from ‘informed.’ Some parents like Alvin Ziegler were “outraged” when they found out about the practice.

Fred Lorey of the Genetic Disease Screening Program quips that if there is any issue, “we’ll destroy it. We’ll even send it back to you if you prefer.” There may be some truth to his sardonic jab at these parents’ indignation, but nothing can replace the necessity of open communication and a respect for people’s autonomy in the medical world. Without informed consent, doctors fail to respect the parents’ role as proxy for their children. That feeling of inadequacy in caring for one’s young can be damaging, and it’s no wonder that fathers like Ziegler react so vociferously. This is not an issue with the genetic tests themselves, and privacy rights are not the issue at hand either since these blood samples are being used for good. Instead, doctors should take greater precautions before rushing DNA to a database. But what do you think? Is privacy perhaps the greater issue here? Is informed consent a model we should follow depending on the situation? In this case, would it just be innane to adhere so religiously to an ideal?

Since informed consent has become such an integral part of the bioethics dialogue, researchers need to make sure parents understand what exactly is being done with their newborns’ blood samples. California should realize soon that that knowledge is imperative; to claim otherwise would be foolish.

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http://www.biopoliticaltimes.org/article.php?list=class&class=20&qty=4

http://www.ktvu.com/news/25821275/detail.html

The Rights of the Incarcerated

The Associated Press released an article last week titled “Treating Prisoners While Jailed Could Stop Disease” claiming just that. Diseases like AIDS, hepatitis, mental illnesses and tuberculosis are statistically more prevalent in the ten million incarcerated people worldwide, two million of whom are in the United States. Therefore, according to the Seena Fazel of the University of Oxford and Jacques Baillargeon of the University of Texas Medical Branch, whose review of prisoner’s health in the western world was published in the medical journal Lancet, treating prisoners could only prove to be advantages in stopping health problems before they hit the public.

The idea that the incarcerated population of the world is absolutely isolated is unrealistic. Figures from the Death Penalty Information Center (DPIC), a non-profit organization providing information and analysis on capital punishment since 1990, put the total number of executions since 1976 in the US at 1,233. Of the remaining prisoners about 1 in 10 are serving life sentences. Even taking into account the number of people who die before completing their sentence, that still leaves a significant portion that will eventually be released into the public. These numbers support the notion that what happens in prison affects the outside world as well.

The World Health Organization advises governments to provide prisoners with the best possible health care free of charge, even when countries are strapped for cash. The U.N. has also released a statement on the treatment of prisoners saying that they should have access to health services without discrimination. But why? Putting aside the argument that it’s for our own benefit, I believe that there is something to be said about human rights and prisoners. The vast majority of the two million prisoners in the United States are not cold-blooded murders. In fact, they generally do not set out to break the law just for the thrill of doing so. It is usually to help a struggling single parent, to pay for medical bills, to feed their families, or just in the spur of the moment. Keeping that in mind, I don’t believe that taking away human rights as a consequence of breaking the law is justified. Instead, we should not underestimate the power of correctional education, advocated for by the likes of Anton Makareno, a renowned Ukranian educational theorist. Because people can indeed change, and they do. For me it is clear that if we can enjoy good health, then prisoners should too. Another debate, however, lies in whether or not prisoners deserve free health care in countries where universal health care is not instituted.

Stem Cell Update

Recently, just within this past month, scientists have discovered and demonstrated methods by which they may turn somatic cells of one type into another type. The two most recent discoveries demonstrate their ability to change skin cells into heart cells and blood cells. This provides a new, unforeseen alternative for stem cell research that has many of those who oppose embryonic stem cell research relieved. How reliable is this new alternative in comparison to the , though? If one completely takes the ethical argument out of the equation, the benefits from the use of embryonic stem cells grossly outweigh the benefits from the use of respecialized somatic stem cells. Even though it is difficult for these stem cells to form tumors of randomly specialized tissue within an organism, it is important to note that it is unknown how many of the hundreds of different types of somatic cells into which these respecialized cells can change and how reliable or efficient this method is. The human race deserves our work to begin now on finding new cures for diseases and conditions, and embryonic stem cell research is still the most reliable and scientifically founded discipline within the stem cell venture. Furthermore, actually, embryonic stem cell research as it exists today is still ethically sound! Embryos today are only harvested from sites at which they would normally be discarded anyway. It would be very difficult to find an ethical argument that states that the human use of those embryos for research to save other humans' lives is not "better" than their disposal. Embryonic stem cell research, even in the light of new developments, still emerges as the best option for stem cell research at this moment.

Gene Therapy: A Fair Form of Negative Eugenics

The creation of Green Fluorescent Protein (GFP) mice represented a revolution in gene therapy technology. Regular mice were given a jellyfish protein that allowed fluorescence – the engineered mice glow naturally (1). Virtually every animal research laboratory in the United States has handled Green Fluorescent Protein (GFP) mice. GFP mice offer laboratories more techniques for studying mouse physiology and metabolism, making research more effective.

GFP mice are examples of positive genetic alteration – humans gave certain desirable traits to other organisms. Genetic therapy, when applied to other human beings, can be considered as two types – positive eugenics (giving desirable traits like intelligence) and negative eugenics (removing undesirable traits like disease). The fairness of positive gene therapy is questionable; since positive gene therapy gives desirable traits, there are concerns of who should receive treatment (2). Negative gene therapy is a eugenic issue that improves fairness, however.

Negative gene therapy effectively addresses the same medical issues as standard health care – diseases should be treated in individuals to better both the individuals themselves and the population. If modern health care is valid, negative gene therapy seems valid as well. However, just like positive gene therapy, negative gene therapy has fairness concerns. The population which receives therapy would be advantaged, in comparison to the untreated population. Eugenics can fix this – application to the truly disadvantaged population would better the overall population without conferring a great advantage to any group. Negative eugenic application of gene therapy would sidestep this inequity in treatment distribution.

Current health care is already unfair to a large amount of the population; negative eugenic gene therapy would better this fairness issue. According to a Gallup poll, sixteen percent of United States adults do not have health insurance. In contrast, about twenty-nine percent of people with incomes less than thirty-six thousand dollars have health insurance (3). American adults with lower incomes cannot afford insurance, often. Negative eugenics directly addresses those disadvantaged individuals.

Distributed based on individual need, negative gene therapy would reduce unfairness by giving therapy to those who do not have access to standard medicines. Further, after an individual is treated with gene therapy, his or her entire progeny benefits from less harmful gene abnormalities. By focusing on improving the less advantaged, gene therapy would help equality of medicine, reducing fairness concerns derived from difference in health care.

The first step of negative gene therapy – detection of diseases – is already common in American hospitals (4). Once gene therapy can safely treat diseases after detection, it seems unjust to not allow gene therapy. Negative eugenic application of gene therapy would level inequities in health care, performing medicine's final goal – bettering the quality of life of as many as possible.

References:

1. http://www.ncbi.nlm.nih.gov/pubmed/9891875?dopt=Abstract

2. http://www.humanenhance.com/NSF_report.pdf

3. http://www.gallup.com/poll/121820/one-six-adults-without-health-insurance.aspx

4. http://scienceinsociety.northwestern.edu/content/articles/2009/research-digest/eugenics/modern-eugenics-building-a-better-person

Putting a Face to Science: Henrietta Lacks' Accidental Contribution to Medicine

In 1951, doctors at The John Hopkins University Hospital cultured a woman's cells that would eventually prove to be one of the most important tools for decades of medical research.

Henrietta Lacks was thirty years old when her husband drove her to the hospital because of complaints about a constant knot in her stomach. Being a poor, black, tobacco farmer-- descending from generations of Virginian slaves--she was forced to go to the John Hopkins Hospital because it was the only one in the area with a "colored wing." After numerous tests, Mrs. Lacks was diagnosed with cervical cancer. Doctors announced that she would need months of radiation therapy, and without her permission, took a slice of her tumor for further laboratory testing. Unfortunately though, Mrs. Lacks died later that year--but her story was far from over.

When doctors took tissue samples from her cancerous tumor, they unknowingly cultured the first line of cells that did not die in a laboratory setting, and instead doubled in number every 24 hours. Dr. George Gey, then the head of tissue research at John Hopkins, had been looking to grow laboratory cells that could survive long enough to be used in medical research--and Mrs. Lack's cells were his answer.

Since their discovery in 1951, it is estimated that there is now more than 50 million metric tons of Mrs. Lacks' cells--the amount of about 100 Empire State buildings and enough to wrap around the earth three times. Known as HeLa, this line of cells is now the standard in research and medical laboratories around the world, and has been vital to many medical discoveries. The HeLa cells were used to test the first polio vaccine, to uncover secrets about cancer, to test the causes and effects of a multitude of viruses, and contributed to important knowledge about the effects of the atomic bomb on human life. Along with this, they went up in the early space missions for scientists to see what happens to human cells in zero gravity; and contributed to essential knowledge for gene mapping, in-vitro fertilization, and cloning. Almost every modern scientific advancement has used the HeLa line of cells in some way.

But Mrs. Lacks' story goes deeper than science--it touches on issues of race, equality, and biomedical ethics. Doctors cultured the first HeLa cells without the informed consent of Mrs. Lacks. This story is one in a long line of the maltreatment of African-Americans in medical research. Though the Tuskegee Syphilis Study is the most famous, Harriet Washington--author of The Medical Apartheid--uncovers many more "cases of blatant misuse of medical practices on unknowing and unsuspecting black patients in the name of furthering science and discovering cures". Why, in the past, have African-American patients been held to a lower standard of medical consent? Informed consent is a fundamental part of biomedical ethics, yet Mrs. Lacks' story shows that this has not always been the case.

Furthermore, Mrs. Lacks' family did not know of the importance of the HeLa cells until almost 20 years after their original discovery. They were only contacted when scientists wanted to use them for tests to uncover more information about their family's genetic history. But because her family was poor and uneducated, much of this new research was done without their informed consent. And even once they understood the full significance of the HeLa cells and the extent to which they were being used, they often asked why they had never once seen any money from the multimillion dollar industry that Mrs. Lacks was responsible for--or more importantly--why they couldn't even afford healthcare.

There really is no way to reverse decades of unethical medical practices--but what is important is to not lose sight of the human face behind science. As research progresses, and new discoveries become increasingly more important as an answer in life or death situations, it is easy to forget that real stories are behind everything. Mrs. Lacks' story is relatively unknown. Though many biology classes mention the HeLa line of cells, few discuss Mrs. Lack or her family. Her story must be made public and used as a jumping off point for further discussion about the ethics of race and inequality in medical research--both past and present.

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Sources:

http://rebeccaskloot.com/the-immortal-life/

http://www.smithsonianmag.com/science-nature/Henrietta-Lacks-Immortal-Cells.html

http://www.npr.org/templates/story/story.php?storyId=123232331

http://www.popsci.com/science/article/2010-01/five-reasons-henrietta-lacks-most-important-woman-medical-history

http://www.newsweek.com/2010/02/15/health-care-injustice.html

http://www.wired.com/magazine/2010/01/st_henrietta/

The (Un?)ethical Elephant in the Room

What do you do when an ethical dilemma arises within another ethical dilemma? Recently, Dr. James E. Mitchell from Texas was punished and could potentially lose his license for helping to design “torture programs for terror suspects imprisoned in Guantanamo” while using improper techniques and lying about his background. According to accusers, “Dr. Mitchell misrepresented his qualifications to the CIA and placed ‘his own career and financial aspirations above the safety of others’ while designing a ‘torture regime’ with a ‘complete lack of scientific base.’” He likewise is linked to a case involving the post-Sept eleventh CIA interrogation methods “that are currently under a criminal torture investigation by the Department of Justice.” Such crimes involve his primary participation in using firm questioning of terror suspects using “sexual humiliation and the drowning technique called waterboarding.” All his actions do not reflect what is allowed or sanctioned by the American Psychological Association nor the Texas licensing board and both have claimed that such torture techniques are illegal and would never be allowed.

And so the elephant in the room remains. It is clear that what Dr. James E Mitchell has done is quite unethical and furthermore, illegal, but how can one attest to the fact that the United States keeps does indeed keep people hostage and is constantly brainstorming methods of interrogation. Is it right for the United States to keep these prisoners hostage? Is that not torture in itself? And now how are we to compensate for what Dr. Mitchell has organized and done? It is strange to think that his fibs have gone unnoticed especially since he has been so integral in assisting the government with such issues. One would think that the government would be very aware of all its employees and representatives. Perhaps and hopefully this will spark some initiative in the government to begin a more careful screening process of all its employees and representatives.

http://www.nytimes.com/2010/11/14/us/14ttlawsuit.html?_r=1&ref=health

Beware of Bad Drugs

The internet has allowed businesses from all over the world to reach a global market, and allow consumers to purchase products that they would not otherwise be able to obtain within their country. At the same time, it also makes regulation of illicit products more difficult, creating a boom in the counterfeit drugs market that is now worth billions globally. 

In countries where the regulatory and policing systems for illicit drugs are weak, counterfeit drugs even creep into the physical market. While they have nearly identical packaging to the real medicines, they contain no active ingredients. This prevents patients from getting the drug that they need, delaying treatment and causing harm to their health. As the public lose faith on their health system, they would be discouraged from conventional medicine and seek less effective therapeutic methods. 

There have been strong international efforts to crack down on distributors and producers of counterfeit drugs. Operation Pangea III, a transnational operation that tackles the problem of counterfeit drugs online, has involved 45 countries. The operation has helped regulators recover $2.6 million worth of illicit and counterfeit drugs, arrested 76 people around the world and shut down 290 illegal websites. With increasing political will and technological assistance, the global problem of counterfeit drugs can be controlled.

Source:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2962118-6/fulltext

"Why did you sterilise me?": Tragedy in Namibia

In June of this year, a troubling report emerged from the south African country of Namibia. Three women, upon being diagnosed as HIV positive, were subsequently sterilized by their doctors without their knowledge and against their will. Further investigation has revealed that these are not the only cases of forced sterilization of HIV positive women in Namibia, with at least 15 having been reported in the past two years.

Looking at this issue for a moment in the frame of relative ethics, it is clear that forced sterilization of HIV positive women in the United States would be unquestionably unethical, both because it usurps the patient’s free will and because we have developed effective and much less invasive ways of preventing an HIV positive mother from transmitting the disease to her children. In a June 6, 2010 post on the blog “women’sbioethicsproject”, the author Ayesha writes, “I can only surmise that the goal for preventing future pregnancies of these women is to halt this method of potential transmission of the HIV virus…. Does [the high mortality rate of HIV in Namibia] make a doctor’s action to perform a sterilization on an HIV+ woman who may not have consented with capacity and competence, or not consented at all, any easier to understand?” Although Ayesha frames her discussion of the controversy only in terms of questions, reading between the lines suggests that she perhaps believes that the particular circumstances in Namibia make forced sterilization ethically acceptable.

But what in truth are the differences between the United States and Namibia with respect to this issue? For one, performing the procedure without informing and gaining the consent of the patient violates the patient’s integrity and most likely goes against the patient’s wishes no matter what country it takes place in, so on this point alone there is no way to consider what was done in Namibia to be ethical (not to mention the fact that if women find out that they will be forcefully sterilized, they will probably not go get tested for HIV, making the situation even worse).

Taking away the aspect of the sterilization being forced (let’s say the patients did give informed consent), it still strikes me that Namibian doctors who advocate for HIV+ women to sterilize themselves are acting unethically. As we discussed in class, effective protocols to lower the rate of HIV transmission from mother to child have been successfully developed and implemented in Africa. Combining these with a nation-wide program to encourage the use of condoms (which would certainly not be expensive to implement compared to the amount of money the US spends on pharmaceuticals), the transmission rate of HIV could be dramatically reduced in a feasible and effective manner without the invasive and psychologically devastating step of sterilizing HIV positive Namibian women (who most certainly have already endured enough pain in their lives). If it seems that I am exaggerating the impact that widespread condom use can have on decreasing the rate of HIV, consider the fact that from 1991 to 2003, new HIV infections in Thailand declined by 90% largely due to a campaign by schools, businesses, media, and the government to promote condoms (see Mechai Viravaidya’s TED talk for more: http://vodpod.com/watch/4556040-how-mr-condom-made-thailand-a-better-place-mechai-viravaidya-at-ted). If there were absolutely no other choice to stem the tide of HIV in Africa, sterilization of HIV positive women might possibly be an ethical solution, but as it stands today it is unjustifiable anywhere in the world.

Sources:

http://womensbioethics.blogspot.com/2010/06/forced-sterilisation-in-namibia.html

http://www.bbc.co.uk/news/10202429

http://vodpod.com/watch/4556040-how-mr-condom-made-thailand-a-better-place-mechai-viravaidya-at-ted